scholarly journals Low- Molecular Weight Heparins (LMWH) Versus Vitamin K Antagonists (VKAs) in the Treatment and Secondary Prevention of Cancer-Associated Venous Thromboembolism (VTE): A Systematic Review and Meta-Analysis of Randomized Controlled Trials (RCTs)

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 1180-1180 ◽  
Author(s):  
Kyaw Zin Thein ◽  
Lukman Tijani ◽  
Thein H. Oo
Keyword(s):  
Systematic Review ◽  
Secondary Prevention ◽  
Cancer Patients ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Vitamin K Antagonists ◽  
Minor Bleeding ◽  
Bleeding Events ◽  
Recurrent Vte ◽  
Prevention Of Cancer

Abstract Introduction: Cancer-associated thrombosis accounts for about 20% of all cases of VTE. VTE increases not only mortality but also morbidity in cancer patients. LMWH is currently recommended over VKAs by major consensus guidelines and it is primarily based on a single, large RCT (CLOT trial) and some smaller studies. However, recently published CATCH trial, which enrolled 900 cancer patients with acute VTE, did not detect a statistically significant reduction in recurrent VTE between tinzaparin and warfarin groups. Hereby, we conducted a systematic review and meta-analysis of RCTs to determine the efficacy and safety of LMWH versus VKA in the treatment and secondary prevention of cancer-associated VTE. Methods: MEDLINE and EMBASE databases were searched through June 30, 2016. All potential studies and their references were evaluated for any additional relevant studies. The RCTs which compare LMWH vs VKA in the treatment of VTE were incorporated in the analysis. Mantel-Haenszel method was used to calculate the estimated pooled risk ratio (RR), and risk difference (RD) with 95% confidence interval (CI). Fixed effects model was applied. Results: A total of 2196 cancer patients with acute VTE from 6 RCTs and a subgroup of another 2 RCTs were eligible for analysis. Enoxaparin, dalteparin, tinzaparin and nadroparin were used on LMWH group and warfarin or acenocoumarol were used on VKA group. The treatment duration was from 3 to 6 months. The VTE incidence was 77 (6.832%) in LMWH group vs 128 (11.973%) in VKA group with a RR of 0.572 (95% CI: 0.436 to 0.750, P < 0.001). The absolute RD in VTE was -0.051 (95% CI: -0.076 to -0.027, P < 0.001). Major bleeding (MB) events were reported in 49 (4.757%) patients in LMWH group vs 45 (4.473%) in VKA group according to the analysis of 6 RCTs. The pooled relative risk for MB was statistically non-significant at 1.049 (95% CI: 0.705 to 1.562, P = 0.812). Composite clinically relevant non-major (CRNM) and minor bleeding events were noted in 143 (13.883%) patients in LMWH group and in 163 (16.203%) in VKA group according to the analysis of 6 RCTs. The RR for composite CRNM and minor bleeding was statistically significant at 0.773 (95% CI: 0.630 to 0.948, P 0.014), favoring LMWHs over VKAs. Conclusions: Our meta-analysis confirms that LMWHs significantly decrease recurrent VTE events compared to VKAs without increasing MB in patients with cancer-associated VTE. LMWH therapy appears to have less CRNM and minor bleeding events compared to VKAs. Figure Figure. Disclosures Oo: Daiichi Sankyo: Research Funding.

A Systematic Review and Meta-Analysis of Randomized Controlled Trials (RCT) in Ambulatory Thromboprophylaxis (ATP) in Patients with Lung Cancer Receiving Chemotherapy

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3825-3825
Author(s):  
Kyaw Zin Thein ◽  
Sai-Ching J Yeung ◽  
Thein H. Oo
Keyword(s):  
Lung Cancer ◽  
Systematic Review ◽  
Cancer Patients ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Control Group ◽  
Number Needed To Treat ◽  
Solid Cancer ◽  
Fixed Effects Model ◽  
Bleeding Events

Abstract Introduction: Lung cancer (LC) is the commonest cause of cancer mortality in USA. Thromboembolism (TE) is the second leading cause of death in cancer patients. The ambulatory thromboprophylaxis (ATP) in solid cancer patients remains uncertain. However, LC is at least an intermediate risk for TE according to Khorana scoring system. We conducted a systematic review and meta-analysis of RCTs to determine the benefit and risk of ATP with low-molecular weight heparins (LMWH) in LC patients receiving chemotherapy. Methods: We performed a comprehensive literature search using MEDLINE and EMBASE databases through June 30, 2016. The RCTs with reduction in TE as a primary or secondary endpoint and the major bleeding (MB) as a safety outcome were included in the analysis. Mantel-Haenszel method was used to calculate the estimated pooled risk ratio (RR), and risk difference (RD) with 95% confidence interval (CI). Fixed effects model was applied. Results: A total of 4315 patients with LC from 4 RCTs and a subgroup of another 2 RCTs were included in our analysis. The prophylactic doses of dalteparin, nadroparin, certoparin, semuloparin and bemiparin were used in the studies. The ATP duration ranged from 3 to 6 months. The randomization ratio was 2 to 1 in PROTECHT study and 1 to 1 in other studies. The TE incidence was 89 (4.007%) in ATP group and 166 (7.927%) in control group with a RR of 0.510 (95% CI: 0.397 to 0.654, P < 0.001). The absolute RD was -0.039 (95% CI: -0.053 to -0.025, P < 0.001) with an estimated number needed to treat (NNT) of 25 to prevent one TE event. MB events were 24 (1.506%) in ATP group compared to 15 (1.019%) in control group according to an analysis of 4 RCTs. The pooled RR for MB was statistically nonsignificant at 1.468 (95% CI: 0.785 to 2.746, P = 0.229). Clinically relevant nonmajor (CRNM) bleeding events were 80 (5.571%) in ATP group and in 24 (1.674%) in control group on an analysis of 4 RCTs. The RR for CRNM bleeding was statistically significant at 3.253 (95% CI: 2.092 to 5.059, P < 0.001). Conclusions: In our study, the relative risk reduction for TE is 49% with a NNT of 25 to prevent one TE without increasing MB. Nevertheless, CRNM bleeding episodes were significant at a ratio of 3.253. Based on the findings, selection of LC patients who are at high TE risk is important. Further studies are necessary to define a subset of LC patients who may benefit from ATP. Figure 1 Figure 1. Figure 2 Figure 2. Disclosures Oo: Daiichi Sankyo: Research Funding.

scholarly journals Tinzaparin in Cancer and Renal Impairment: A Systematic Review Focusing on Safety

2020 ◽  
Author(s):  
Ioannis Vathiotis ◽  
Nikolaos Syrigos ◽  
Evangelos Dimakakos
Keyword(s):  
Systematic Review ◽  
Renal Impairment ◽  
Creatinine Clearance ◽  
Cancer Patients ◽  
Major Bleeding ◽  
Severe Renal Impairment ◽  
Vitamin K Antagonists ◽  
Bleeding Events ◽  
Increased Risk ◽  
Therapeutic Doses

Abstract Purpose: Low-molecular-weight heparins are approved for primary and secondary venous thromboembolism prevention. The purpose of this systematic review is to provide an update regarding the safety profile of tinzaparin sodium, prescribed either as a prophylactic or as a therapeutic regimen for VTE in cancer patients and individuals suffering from renal impairment. Method: We identified and studied clinical studies from 2000 until 2020, reporting safety outcomes for cancer patients and individuals with renal impairment receiving either prophylactic or therapeutic doses of tinzaparin. Results: In patients with cancer major bleeding rates fluctuate between 0.8% and 7%; reported major bleeding rates for non-cancer patients with renal impairment on prophylactic tinzaparin regimens were 0%. Non-cancer patients on therapeutic tinzaparin regimens exhibited major bleeding in 0 to 2.3% of cases; major bleeding rates were higher for cancer patients with renal impairment receiving therapeutic doses of tinzaparin (4.3 to 10%). Patients on tinzaparin exhibit significantly lower rates of clinically relevant nonmajor bleeding events in comparison with those on vitamin K antagonists. Bioaccumulation of tinzaparin is not correlated with age, body weight or creatinine clearance. Periodic administration of either prophylactic or therapeutic doses of tinzaparin does not result in bioaccumulation, even in patients with severe renal impairment and creatinine clearance < 20 ml/min. Conclusion: Tinzaparin is safe and can be used without dose adjustment in patients with severe renal impairment and creatinine clearance > 20 ml/min. Tinzaparin represents a thoroughly studied and safe choice for special populations at increased risk for thrombosis and bleeding.

scholarly journals Systematic review and meta-analysis of the efficacy and safety of apixaban compared to rivaroxaban in acute VTE in the real world

2019 ◽  
Vol 3 (15) ◽  
pp. 2381-2387 ◽  
Author(s):  
Madan Raj Aryal ◽  
Rohit Gosain ◽  
Anthony Donato ◽  
Han Yu ◽  
Anjan Katel ◽  
...  
Keyword(s):  
Real World ◽  
Meta Analysis ◽  
Indirect Comparison ◽  
Cochrane Library ◽  
Minor Bleeding ◽  
Efficacy And Safety ◽  
Bleeding Events ◽  
The Real ◽  
Recurrent Vte ◽  
Meta Analyses

Abstract Both apixaban and rivaroxaban have been approved for use in acute venous thromboembolism (VTE). Although indirect comparison through network meta-analyses of randomized trials have been performed to compare the efficacy and safety of these agents, further comparison between these agents was lacking until recently. We sought to systematically review and carry out a meta-analysis of studies to further compare apixaban with rivaroxaban from multiple studies done in the real-world settings. Studies comparing rivaroxaban with apixaban in patients with acute VTE were identified through electronic literature searches of MEDLINE, EMBASE, Scopus, and the Cochrane library up to May 2019. Study-specific risk ratios (RRs) were calculated and combined using a random-effects model meta-analysis. In an analysis involving 24 041 patients, recurrent VTE within 6 months occurred in 56 of 4897 patients (1.14%) in the apixaban group and 258 of 19 144 patients (1.35%) in the rivaroxaban group (RR, 0.89; 95% confidence interval [CI], 0.67-1.19; P = .45). Clinically relevant major bleeding occurred in 85 of 11 559 patients (0.74%) in the apixaban group and 350 of 33 909 patients (1.03%) in the rivaroxaban group (RR, 0.73; 95% CI, 0.58-0.93; P = .01). Clinically relevant nonmajor bleeding occurred in 169 of 3417 patients (4.95%) in the apixaban group and 1094 of 12 475 patients (8.77%) in the rivaroxaban group (RR, 0.59; 95% CI, 0.50-0.70; P &lt; .01). Apixaban shows equivalent efficacy in prevention of recurrent VTE but decreased risk of major and minor bleeding events compared with rivaroxaban.

Oral anticoagulant use in patients with morbid obesity: A systematic review and meta-analysis

2021 ◽  
Author(s):  
Tzu-Fei Wang ◽  
Marc Carrier ◽  
Karine Fournier ◽  
Deborah M. Siegal ◽  
Grégoire Le Gal ◽  
...  
Keyword(s):  
Systematic Review ◽  
Morbid Obesity ◽  
Major Bleeding ◽  
Observational Studies ◽  
Meta Analysis ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Efficacy And Safety ◽  
Systemic Embolism ◽  
Recurrent Vte

Objectives: Obesity is associated with increased risks of atrial fibrillation (AF) and venous thromboembolism (VTE) for which anticoagulation is commonly used. However, data on the efficacy and safety of oral anticoagulants in patients with morbid obesity are limited. Methods: We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs) for AF or VTE in patients with morbid obesity. Results: We included 3 randomized controlled trials (5 studies) and 18 observational studies in adult patients with a body weight ≥ 120 kg, body mass index (BMI) ≥ 40 kg/m2 or classified as morbid obesity who received DOACs or VKAs for AF or VTE (N=77,687). The primary efficacy outcome was stroke/systemic embolism or recurrent VTE, and the primary safety outcome was major bleeding. DOACs were associated with a pooled incidence rate of stroke/systemic embolism of 1.16 per 100 person-years, compared to 1.18 with VKAs. The incidence of recurrent VTE on DOACs was 3.83 per 100 person-years, compared to 6.81 on VKAs. In both VTE and AF populations, DOACs were associated with lower risks of major bleeding compared to VKAs. However, all observational studies had moderate to serious risks of bias. Conclusions: Patients with morbid obesity on DOACs had similar risks of stroke/systemic embolism, lower rates of recurrent VTE and major bleeding events compared to those on VKAs. However, the certainty of evidence was low given that studies were mostly observational with high risk of confounding.

Clinical Impact and Course of Anticoagulant-Related Major Bleeding in Cancer Patients

2018 ◽  
Vol 118 (01) ◽  
pp. 174-181 ◽  
Author(s):  
Noémie Kraaijpoel ◽  
Nick van Es ◽  
Suzanne Bleker ◽  
Marjolein Brekelmans ◽  
Elise Eerenberg ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Major Bleeding ◽  
Clinical Presentation ◽  
Meta Analysis ◽  
Vitamin K Antagonists ◽  
Factor Xa ◽  
Phase Iii ◽  
Bleeding Events ◽  
Increased Risk ◽  
Major Bleeding Events

AbstractCancer patients with venous thromboembolism (VTE) have a two- to six-fold increased risk of anticoagulant-related major bleeding events compared with VTE patients without cancer. It is unknown whether major bleeding events are more severe in cancer patients than in those without cancer. Individual patient data from four randomized phase III trials that compared factor Xa inhibitors and vitamin K antagonists for the treatment of VTE were used to compare the severity of major bleeding events in patients with and without cancer. Using predefined criteria, the severity of the clinical presentation and course of major bleeding events were classified into four categories of increasing severity. A one-stage meta-analysis was used to evaluate the effect of cancer on the severity of the clinical presentation and course by estimating crude odds ratios (ORs) and ORs adjusted for age, sex and anticoagulant type with 95% confidence intervals (CIs). The study group comprised 290 patients with major bleeding, of whom 50 (17%) had cancer. The clinical presentation was judged to be severe (category 3 or 4) in 38% of patients with cancer and 44% of patients without cancer (adjusted OR, 0.90; 95% CI, 0.47–1.72). The clinical course was found to be severe in 20 and 25% of patients with and without cancer, respectively (adjusted OR, 0.75; 95% CI, 0.35–1.61). The present study suggests that the clinical presentation and course of anticoagulant-related major bleeding events are not more severe in cancer patients than in patients without cancer. This may be reassuring for physicians who treat cancer patients with anticoagulant-related bleeding.

scholarly journals The Effect of Metformin on Mortality Among Diabetic Cancer Patients: A Systematic Review and Meta-analysis

2017 ◽  
Vol 1 (1) ◽  
Author(s):  
Xun Cao ◽  
Yaopan Wu ◽  
Jing Wang ◽  
Kuiyuan Liu ◽  
Xin Wang
Keyword(s):  
Breast Cancer ◽  
Systematic Review ◽  
Cancer Patients ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Cancer Site ◽  
Diabetic Patients ◽  
Metformin Treatment ◽  
Breast Cancer Patients ◽  
The Past

Abstract Background Most data suggest that cancer patients with diabetes have worse outcomes, which may be reversed with metformin. Metformin might modulate the clinical outcomes of diabetic cancer patients. We performed a systematic review and meta-analysis based on published studies over the past five years to summarize the effects of metformin on diabetic cancer patients. Methods We systematically searched for studies that were published over the past five years. Then, we evaluated these studies for inclusion and extracted the relevant data. The summary risk estimates for the association between metformin treatment and all-cause mortality (ACM) and cancer-specific mortality (CSM) were analyzed using random or fixed-effects models. Stratified analyses by cancer site and country were also conducted. Results Based on the 42 studies included in our analysis (37 015 diabetic cancer patients), we found a significant benefit associated with metformin treatment on survival corresponding to 27% and 26% reductions in ACM (hazard ratio [HR] = 0.73, 95% confidence interval [CI] = 0.68 to 0.79, P < .001) and CSM (HR = 0.74, 95% CI = 0.64 to 0.86, P < .001), respectively. The ACM rates for colorectal cancer, endometrial cancer, breast cancer, prostate cancer, and ovarian cancer showed significant benefits associated with metformin treatment in our stratified analyses by cancer site. Stratified analyses by cancer site also showed a significant reduction in CSM for breast cancer. This association between metformin treatment and reduced CSM for diabetic breast cancer patients was also observed in our country subgroup analyses. Conclusions We found an association between metformin exposure and reduced ACM and CSM in diabetic patients with cancer. Our findings suggest that metformin treatment could be an effective treatment option for diabetic cancer patients.

scholarly journals A Systematic Review and Meta- Analysis of Randomized Controlled Trials on Primary Ambulatory Thromboprophylaxis (PATP) in Patients with Gastrointestinal Cancers Receiving Chemotherapy

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3679-3679
Author(s):  
Kyaw Zin Thein ◽  
Donald P. Quick ◽  
Thein Hlaing Oo
Keyword(s):  
Systematic Review ◽  
High Risk ◽  
Cancer Patients ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
Control Group ◽  
Number Needed To Treat ◽  
Solid Cancer ◽  
Gastrointestinal Cancers

Introduction: PATP in solid cancer patients remains uncertain and is not routinely recommended although thrombosis is shown to be the second leading cause of death in cancer patients. Many studies failed to demonstrate in solid cancer outpatients improvement in overall survival despite decreasing venous thromboembolism (VTE) rates by PATP. We conducted a systematic review and meta-analysis of RCTs to determine the benefit and risk of PATP with low-molecular weight heparins (LMWHs) and direct oral anticoagulants (DOACs) in patients with gastrointestinal cancers receiving chemotherapy. Methods: We performed a comprehensive literature search using MEDLINE and EMBASE databases through June 30, 2019. The references of all potential studies were also reviewed for any additional relevant studies. The RCTs with reduction in VTE as a primary or secondary endpoint and the major bleeding (MB) as a safety outcome were incorporated in the analysis. The primary meta- analytic approach was a fixed effects model using the Mantel-Haenszel (MH) method. It was used to calculate the estimated pooled risk ratio (RR), and risk difference (RD) with 95% confidence interval (CI). Heterogeneity was assessed with Cochran's Q- statistic. Results: A total of 1,932 patients with gastric, gastroesophageal junctional (GEJ) and colorectal cancers from a subgroup of three RCTs were included in our meta-analysis. The prophylactic doses of LMWHs and DOAC (rivaroxaban) were used in the studies. The duration of LMWH and DOAC ranged from 3 to 6 months. The randomization ratio was 2 to 1 in PROTECHT study and 1 to 1 in all other studies. The I2 statistic for heterogeneity was 0, suggesting homogeneity among RCTs. The VTE incidence was 13 (1.26%) in PATP group and 23 (2.55%) in control group with a RR of 0.49 (95% CI: 0.25 to 0.96, P = 0.04). The absolute RD in VTE was -0.01 (95% CI: -0.03 to -0.00, P 0.04) with an estimate of the number needed to treat (NNT) of 78 to prevent one VTE event. In a subset of patients with gastric and GEJ cancers (n=587), the VTE incidence was 4 (1.37%) in PATP group and 10 (3.40%) in control group with a RR of 0.40 (95% CI: 0.13 to 1.24, P = 0.11). Conclusions: In our study, the relative risk reduction is 48% with a NNT of 78 to prevent one VTE in ambulatory patients with gastrointestinal cancers. Nevertheless, there is no statistically significant reduction in VTE events in a subset of gastric and GEJ cancers which are considered high risk in Khorana score. Based on the findings, PATP is not recommended in patients with gastrointestinal cancers on chemotherapy at this time. Further studies are necessary to define high risk subsets of gastrointestinal cancer patients receiving chemotherapy who may benefit from PATP. Disclosures Oo: Medical Education Speakers Network: Honoraria; Janssen and Janssen: Other: site co-investigator.

Left Ventricular Thrombus Therapy With Direct Oral Anticoagulants Versus Vitamin K Antagonists: A Systematic Review and Meta-Analysis

2020 ◽  
pp. 107424842097756
Author(s):  
Carolina Saleiro ◽  
João Lopes ◽  
Diana De Campos ◽  
Luís Puga ◽  
Marco Costa ◽  
...  
Keyword(s):  
Systematic Review ◽  
Vitamin K ◽  
Meta Analysis ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Left Ventricular ◽  
Systemic Embolism ◽  
Bleeding Events ◽  
Ventricular Thrombus

Background: Current guidelines recommend vitamin K antagonists (VKAs) for left ventricular thrombus (LVT) resolution. Direct oral anticoagulants (DOACs) are increasingly evaluated as alternatives to the standard of care in anticoagulation. Methods: We performed a systematic review and meta-analysis to assess the use of DOACs vs VKAs for LVT treatment. The occurrence of LVT resolution, systemic embolism (SE) or stroke, and bleeding events were compared during follow-up using random-effects analysis. Results: The 5 included studies were all observational (a total of 828 patients). Of these, 284 patients (34%) were treated with DOACs, and 544 (66%) treated with VKAs. Thrombus resolution was similar for both methods (pooled odds ratio [OR], 0.91; 95% CI, 0.47-1.75; I2 = 63%; P = .78). The incidence of SE or stroke was also similar (pooled OR, 1.59; 95% CI, 0.85-2.97; I2 = 0%; P = .14). Clinically relevant bleeding incidence was similar for both groups (pooled OR, 0.66; 95% CI, 0.31-1.40; I2 = 0%; P = .28), although all bleeding events were less frequent in the DOAC group (pooled OR, 0.49; 95% CI, 0.26-0.90; I2 = 0%; P = .02). Conclusion: Our systematic review and meta-analysis suggests DOACs were as effective as VKAs for LVT resolution, with a similar risk of systemic embolism/stroke and clinically relevant bleeding. These results, obtained from observational studies, are not definitive and hence randomized controlled trials are needed. Nevertheless, our analysis identifies key experimental features required in future studies.

Risk of Bleeding from Primary Thromboprophylaxis (PTP) in Patients with Solid Cancer Receiving Chemotherapy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials (RCT)

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3820-3820
Author(s):  
Kyaw Zin Thein ◽  
Aung M Tun ◽  
Sai-Ching J Yeung ◽  
Thein H. Oo
Keyword(s):  
Systematic Review ◽  
Cancer Patients ◽  
Meta Analysis ◽  
Bleeding Event ◽  
Bleeding Risk ◽  
Risk Difference ◽  
Control Group ◽  
Solid Cancer ◽  
Bleeding Events ◽  
Risk Of Bleeding

Abstract Introduction: Thrombosis is the second leading cause of death in cancer patients. Hypothetically, prognosis might be improved by preventing thrombotic events by PTP. PTP has to be outweighed with the bleeding risk from PTP benefit. Moreover, PTP in ambulatory cancer patients remains uncertain. We performed a systematic review and meta-analysis of RCTs to determine the risk of major bleeding (MB) and clinically relevant non-major (CRNM) bleeding from PTP with low-molecular weight heparins (LMWH) in solid cancer patients receiving chemotherapy. Methods: We systematically conducted a comprehensive literature search using MEDLINE and EMBASE databases through May 31, 2016. The RCTs with MB and CRNM bleeding as safety outcomes were included in the analysis. Mantel-Haenszel method was used to calculate the estimated pooled risk ratio (RR), and risk difference (RD) with 95% confidence interval (CI). Random effects model was applied. Results: 12 RCTs with a total of 8643 patients were eligible for analysis. Dalteparin, nadroparin, certoparin, semuloparin and bemiparin were used in the studies. 9 studies utilized prophylactic doses, while one used intermediate doses and 2 employed therapeutic dose. The PTP duration was from 6 weeks to 6 months. MB events were reported in 67 (1.486%) patients on PTP compared to 46 (1.112%) in control group. The pooled RR for MB was statistically nonsignificant at 1.341 (95% CI: 0.917 to 1.960, P = 0.130). CRNM bleeding events were noted in 209 (4.637%) in PTP group and 106 (2.563%) in control group. The RR for CRNM bleeding was statistically significant at 1.729 (95% CI: 1.017 to 2.938, P = 0.043). The absolute RD in CRNM bleeding was 0.020 (95% CI: 0.004 to 0.035, P = 0.012) with an estimated number needed to harm (NNH) of 48 to cause one CRNM bleeding event. Conclusions: Approximately 60 patients are needed to be treated with PTP to prevent one symptomatic venous thrombosis among all ambulatory unselected cancer patients on chemotherapy in a previous meta-analysis. Our meta-analysis revealed that PTP contributed an increase in CRNM bleeding events with NNH of 48. The risk of bleeding should not be underestimated and more RCTs are required before making any recommendations. Figure 1 Figure 1. Figure 2 Figure 2. Disclosures Oo: Daiichi Sankyo: Research Funding.

Major bleeding rates after prophylaxis against venous thromboembolism: Systematic review, meta-analysis, and cost implications

2004 ◽  
Vol 20 (4) ◽  
pp. 405-414 ◽  
Author(s):  
James Muntz ◽  
David A Scott ◽  
Adam Lloyd ◽  
Matthias Egger
Keyword(s):  
Systematic Review ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Bleeding Events ◽  
Relative Risks ◽  
Major Orthopedic Surgery ◽  
Anticoagulant Prophylaxis ◽  
Mean Cost

Objectives: The frequency and consequences of major bleeding associated with anticoagulant prophylaxis for prevention of venous thromboembolism is examined.Methods: We conducted a systematic review and meta-analysis of controlled trials that reported rates of major bleeding after pharmaceutical thromboprophylaxis in patients undergoing major orthopedic surgery. Thromboprophylactic agents were divided into four groups:warfarin/other coumarin derivatives (WARF), unfractionated heparin (UFH), low molecular weight heparin (LMWH), and pentasaccharide (PS). Meta-analysis was conducted comparing LMWH with each of WARF, UFH, and PS. The frequency of re-operation due to major bleeding was reviewed and combined with published costs to estimate the mean cost of managing major bleeding events in these patients.Results: Twenty-one studies including 20,523 patients met inclusion criteria for the meta-analysis. No evidence of significant between-trial heterogeneity in risk ratios was found. Combined (fixed effects) relative risks (RR) of major bleeding compared with LMWH were WARF – RR 0.59 (95 percent confidence interval [CI], 0.44–0.80); UFH – RR 1.52 (95 percent CI, 1.04–2.23); PS – RR 1.52 (95 percent CI, 1.11–2.09). Seventy-one studies including 32,433 patients were included in the review of consequences of major bleeding. We estimated that the average cost of major bleeding is $113 per patient receiving thromboprophylaxis.Conclusions: LMWH results in fewer major bleeding episodes than UFH and PS but more than WARF. These events are costly and clinically important.

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